Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

December 27, 2018 updated by: Bagcilar Training and Research Hospital

Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size

Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

710

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Bagcilar
      • İstanbul, Bagcilar, Turkey, 34100
        • Recruiting
        • Tolga Karacan
        • Contact:
        • Sub-Investigator:
          • Gulfem Basol, M.D
        • Sub-Investigator:
          • Fatma V Ferit, Prof.Dr.M.D
        • Sub-Investigator:
          • Eser Ozyurek, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
  2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion Criteria:

  • suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group (patients with OMA)

I) Untreated patients (n=142)

II) Dienogest (n=142)

III) Dienogest/Estradiol valerate+Dienogest (n=142)
Drug: Estradiol valerate/dienogest
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
Other Names:
  • Dienogest
Sham Comparator: Control Group(patients without OMA)

I) Untreated patients (n=142)

II) Dienogest/Estradiol valerate+Dienogest (n=142)
Drug: Estradiol valerate/dienogest
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
Other Names:
  • Dienogest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian reserve
Time Frame: up to 24 months
The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrioma Size
Time Frame: up to 24 months
The investigators evaluate endometrioma size (centimeter) using ultrasonography.
up to 24 months
Pain Score
Time Frame: up to 24 months
Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Collaborators

Kocaeli Derince Education and Research Hospital
Suleymaniye Birth And Women's Health Education And Research Hospital

Investigators

  • Study Director: Engin Oral, Prof.Dr. M.D, Istanbul University Cerrahpasa Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.11.1.01.082.r1.101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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